Pall LeukoGuard LGB LGB

GUDID 35034480004056

Pall LeukoGuard LGB Arterial Line Leukocyte Reduction Filter with Bypass Loop

PALL CORPORATION

Cardiopulmonary bypass system filter, arterial blood line Cardiopulmonary bypass system filter, arterial blood line Cardiopulmonary bypass system filter, arterial blood line Cardiopulmonary bypass system filter, arterial blood line Cardiopulmonary bypass system filter, arterial blood line Cardiopulmonary bypass system filter, arterial blood line Cardiopulmonary bypass system filter, arterial blood line Cardiopulmonary bypass system filter, arterial blood line Cardiopulmonary bypass system filter, arterial blood line Cardiopulmonary bypass system filter, arterial blood line Cardiopulmonary bypass system filter, arterial blood line Cardiopulmonary bypass system filter, arterial blood line Cardiopulmonary bypass system filter, arterial blood line Cardiopulmonary bypass system filter, arterial blood line Cardiopulmonary bypass system filter, arterial blood line Cardiopulmonary bypass system filter, arterial blood line Cardiopulmonary bypass system filter, arterial blood line Cardiopulmonary bypass system filter, arterial blood line Cardiopulmonary bypass system filter, arterial blood line Cardiopulmonary bypass system filter, arterial blood line Cardiopulmonary bypass system filter, arterial blood line Cardiopulmonary bypass system filter, arterial blood line Cardiopulmonary bypass system filter, arterial blood line Cardiopulmonary bypass system filter, arterial blood line Cardiopulmonary bypass system filter, arterial blood line Cardiopulmonary bypass system filter, arterial blood line Cardiopulmonary bypass system filter, arterial blood line Cardiopulmonary bypass system filter, arterial blood line Cardiopulmonary bypass system filter, arterial blood line Cardiopulmonary bypass system filter, arterial blood line Cardiopulmonary bypass system filter, arterial blood line
Primary Device ID35034480004056
NIH Device Record Keya75be26c-1b98-4cc1-8d5f-16e3e97d83f8
Commercial Distribution StatusIn Commercial Distribution
Brand NamePall LeukoGuard LGB
Version Model NumberLGB
Catalog NumberLGB
Company DUNS002054419
Company NamePALL CORPORATION
Device Count1
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)645-6578
EmailQAMedical@pall.com
Phone+1(800)645-6578
EmailQAMedical@pall.com
Phone+1(800)645-6578
EmailQAMedical@pall.com
Phone+1(800)645-6578
EmailQAMedical@pall.com
Phone+1(800)645-6578
EmailQAMedical@pall.com
Phone+1(800)645-6578
EmailQAMedical@pall.com
Phone+1(800)645-6578
EmailQAMedical@pall.com
Phone+1(800)645-6578
EmailQAMedical@pall.com
Phone+1(800)645-6578
EmailQAMedical@pall.com
Phone+1(800)645-6578
EmailQAMedical@pall.com
Phone+1(800)645-6578
EmailQAMedical@pall.com
Phone+1(800)645-6578
EmailQAMedical@pall.com
Phone+1(800)645-6578
EmailQAMedical@pall.com
Phone+1(800)645-6578
EmailQAMedical@pall.com
Phone+1(800)645-6578
EmailQAMedical@pall.com
Phone+1(800)645-6578
EmailQAMedical@pall.com
Phone+1(800)645-6578
EmailQAMedical@pall.com
Phone+1(800)645-6578
EmailQAMedical@pall.com
Phone+1(800)645-6578
EmailQAMedical@pall.com
Phone+1(800)645-6578
EmailQAMedical@pall.com
Phone+1(800)645-6578
EmailQAMedical@pall.com
Phone+1(800)645-6578
EmailQAMedical@pall.com
Phone+1(800)645-6578
EmailQAMedical@pall.com
Phone+1(800)645-6578
EmailQAMedical@pall.com
Phone+1(800)645-6578
EmailQAMedical@pall.com
Phone+1(800)645-6578
EmailQAMedical@pall.com
Phone+1(800)645-6578
EmailQAMedical@pall.com
Phone+1(800)645-6578
EmailQAMedical@pall.com
Phone+1(800)645-6578
EmailQAMedical@pall.com
Phone+1(800)645-6578
EmailQAMedical@pall.com
Phone+1(800)645-6578
EmailQAMedical@pall.com

Device Dimensions

Pore Size40 Micrometer
Device Size Text, specify0
Pore Size40 Micrometer
Device Size Text, specify0
Pore Size40 Micrometer
Device Size Text, specify0
Pore Size40 Micrometer
Device Size Text, specify0
Pore Size40 Micrometer
Device Size Text, specify0
Pore Size40 Micrometer
Device Size Text, specify0
Pore Size40 Micrometer
Device Size Text, specify0
Pore Size40 Micrometer
Device Size Text, specify0
Pore Size40 Micrometer
Device Size Text, specify0
Pore Size40 Micrometer
Device Size Text, specify0
Pore Size40 Micrometer
Device Size Text, specify0
Pore Size40 Micrometer
Device Size Text, specify0
Pore Size40 Micrometer
Device Size Text, specify0
Pore Size40 Micrometer
Device Size Text, specify0
Pore Size40 Micrometer
Device Size Text, specify0
Pore Size40 Micrometer
Device Size Text, specify0
Pore Size40 Micrometer
Device Size Text, specify0
Pore Size40 Micrometer
Device Size Text, specify0
Pore Size40 Micrometer
Device Size Text, specify0
Pore Size40 Micrometer
Device Size Text, specify0
Pore Size40 Micrometer
Device Size Text, specify0
Pore Size40 Micrometer
Device Size Text, specify0
Pore Size40 Micrometer
Device Size Text, specify0
Pore Size40 Micrometer
Device Size Text, specify0
Pore Size40 Micrometer
Device Size Text, specify0
Pore Size40 Micrometer
Device Size Text, specify0
Pore Size40 Micrometer
Device Size Text, specify0
Pore Size40 Micrometer
Device Size Text, specify0
Pore Size40 Micrometer
Device Size Text, specify0
Pore Size40 Micrometer
Device Size Text, specify0
Pore Size40 Micrometer
Device Size Text, specify0

Device Identifiers

Device Issuing AgencyDevice ID
GS105034480004055 [Primary]
GS135034480004056 [Package]
Contains: 05034480004055
Package: case [8 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DTMFilter, blood, cardiopulmonary bypass, arterial line

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[35034480004056]

Ethylene Oxide

[35034480004056]

Ethylene Oxide

[35034480004056]

Ethylene Oxide

[35034480004056]

Ethylene Oxide

[35034480004056]

Ethylene Oxide

[35034480004056]

Ethylene Oxide

[35034480004056]

Ethylene Oxide

[35034480004056]

Ethylene Oxide

[35034480004056]

Ethylene Oxide

[35034480004056]

Ethylene Oxide

[35034480004056]

Ethylene Oxide

[35034480004056]

Ethylene Oxide

[35034480004056]

Ethylene Oxide

[35034480004056]

Ethylene Oxide

[35034480004056]

Ethylene Oxide

[35034480004056]

Ethylene Oxide

[35034480004056]

Ethylene Oxide

[35034480004056]

Ethylene Oxide

[35034480004056]

Ethylene Oxide

[35034480004056]

Ethylene Oxide

[35034480004056]

Ethylene Oxide

[35034480004056]

Ethylene Oxide

[35034480004056]

Ethylene Oxide

[35034480004056]

Ethylene Oxide

[35034480004056]

Ethylene Oxide

[35034480004056]

Ethylene Oxide

[35034480004056]

Ethylene Oxide

[35034480004056]

Ethylene Oxide

[35034480004056]

Ethylene Oxide

[35034480004056]

Ethylene Oxide

[35034480004056]

Ethylene Oxide

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2015-10-21

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30636207302442 - Pall® Transfer/Freezing Bag Set2019-09-23 Two transfer bags (150 mL and 200 mL) and one 25 mL freezing bag for blood component processing and freezing.
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